Americans spend about $33 billion a year on dietary supplements, many of which promise things like weight loss, enhanced cognitive function and increased muscle mass. According to Dr. Pieter Cohen, a practicing MD and professor at Harvard University, supplements purporting such benefits—in particular weight-loss pills—can largely be divided into two categories: those that work and those that are safe. This stance is based on a disturbing and widespread practice among supplement makers to add amphetamine-like stimulants to their products. Some of these stimulants have never been tested on humans. Those that have been tested are widely considered dangerous.
While ostensibly overseen by the FDA, the supplement industry is regulated by the Dietary Supplement Health and Education Act of 1994 (DSHEA), a law that shields supplements from the inconvenience of scientific scrutiny. The DSHEA, Dr. Cohen wrote in the Harvard Public Health Review, "creates perverse incentives for unscrupulous manufacturers to out-compete legitimate companies by adding undeclared, illegal ingredients including prescription medications, banned drugs and even entirely novel chemical compounds."
To make matters worse, as detailed in a recent New York Times story, there is a suspiciously well-traveled revolving door between the supplement industry and the agency that is supposed to regulate it. This classic case of the coyote guarding the hen house is putting people's health at risk, Cohen explained to me via email.
One common practice used by manufacturers is to claim use of certain plant extracts in their ingredient lists, but instead of these extracts, various synthetic stimulants are discreetly added.
Cohen and colleagues have published several studies that have found such undeclared ingredients in multiple supplements. For example, products containing the synthetic stimulant α-
According to Dr. Pieter Cohen, supplements purporting such benefits—in particular weight-loss pills—can largely be divided into two categories: those that work and those that are safe.
Two years ago, FDA scientists investigated several muscle-building and weight loss pills that claimed to contain an extract of the desert shrub acacia rigidula. They did not, in fact, contain the extract, but instead contained the undeclared synthetic stimulant β-
The FDA, meanwhile, has declined to ban the supplements it found to contain BMPEA. Nor would it issue any sort of alert, or even identify the supplements to the public because, it said in a statement, "[O]ur review of the available information on products containing BMPEA does not identify a specific safety concern at this time."
Since the FDA refused to name the supplement brands it found to contain BMPEA, Cohen and colleagues tested 21 supplements that claimed to contain acacia rigidula extract. Their April 7 paper reveals that 11 of these brands contain BMPEA instead. "Acacia rigidula is just industry code for synthetic stimulants," Cohen told me. And since the FDA has done nothing to reprimand the supplement manufacturers that are sneaking BMPEA into their products, the practice has apparently increased. As the April 7 study notes, "Since the FDA discovered BMPEA in supplements, the percentage of brands of acacia rigidula supplements that contain BMPEA has appeared to increase from 42.9 percent in 2012 to 52.4 percent in 2014."
The CDC identified nearly one hundred people who had developed hepatitis from OxyElite Pro. Forty-seven required hospitalization, three needed liver transplants, and one died.
Some supplement manufacturers claim that BMPEA is naturally occurring in acacia rigidula. In a statement provided to CBS News, Hi-Tech Pharmaceuticals, which makes several supplements that list acacia rigidula on the label, wrote: "Hi-Tech has sold over 1 billion doses since 2003 of acacia rigidula and its alkaloids—including BMPEA—and have conducted numerous studies of these alkaloids and believe them to be safe and effective when used as directed."
Cohen disagrees. "BMPEA has never been found in acacia rigidula or any other plant," he emailed. Moreover, "FDA's data suggests that the natural compounds found in acacia rigidula are not present in these supplements regardless of the presence of BMPEA."
Such adulteration is widespread. And with the FDA doing little to keep tabs on the damage it may be causing, much of this burden is falling on the shoulders of concerned physicians. Cohen's Harvard Public Health Review article relates the story of a Hawaiian liver surgeon who began noticing a dramatic increase in unexplained liver failures last summer. She alerted the Centers for Disease Control and Prevention, which investigated the matter and linked the liver failures to a weight-loss supplement called OxyElite Pro. The CDC identified nearly one hundred people who had developed hepatitis from OxyElite Pro. Forty-seven required hospitalization, three needed liver transplants, and one died.
Cohen also wrote that the untested, unregulated synthetic DMAA, which his team found in many over-the-counter supplements, is being investigated as a cause of strokes, heart disease and sudden death.
When it became clear that people were getting sick, and possibly dying, from DMAA, the FDA began working to get it banned. But Cohen and other critics point out that instead of behaving proactively to keep people safe, the agency is waiting for people to develop health issues, and then reacting.
"The FDA only moved against DMAA when deaths were prominently highlighted in the New York Times and on NBC. FDA only responded to the OxyElite Pro hepatitis outbreak after the CDC requested their help," Dr. Cohen told me. "Even when they could easily foresee problems with products, they choose to wait until people die. This is beyond irresponsible."
At the heart of this regulatory dysfunction is a trade group with the ironic name Natural Products Association, which has spent millions of dollars lobbying to keep regulations on the supplement industry as lax as possible. As the Times reported, two of the top FDA officials in charge of policing the supplements industry were formerly employed by the Natural Products Association, where they worked to block laws that would have prevented some very unnatural products from showing up in supplements.
One former senior executive at the Natural Products Association, Daniel Fabricant, directed the FDA's division of dietary supplement programs between 2011 and 2014. He was replaced by another former executive at the same trade group. Fabricant has since returned to the Natural Products Association as its chief executive.
On April 6, New York's attorney general Eric T. Schneiderman led a group of 14 state attorneys general in demanding that Congress provides the FDA with more power to regulate supplements. But if the FDA is stocked with industry insiders, who is to say that even stronger laws will be enforced?